LED Therapy Mask (MN1, M226)

The LED Therapy Mask (models MN1, M226) is a wearable, home-use phototherapy device that emits narrow-band LED light at multiple wavelengths to treat facial wrinkles, mild-to-moderate inflammatory acne, and provide topical heating for arthritis and muscle conditions. It consists of a mask unit containing LEDs, a controller with rechargeable lithium battery, straps, and a charging cable. The device produces red (630nm), blue (460nm), infrared (850nm), and mixed light wavelengths depending on the selected mode.

The subject device uses LEDs generating four wavelengths (red 630nm, blue 470nm, infrared 850nm, mixed 630nm+850nm) with intensity ranges of 0.89–4.09 mW/cm², powered by a built-in 3.7V 2500mAh lithium battery. Key differences from the predicate include slightly different blue wavelength (470nm vs 460nm), lower mixed-light intensity (0.95–2.64 mW/cm² vs 9.0–12.0 mW/cm²), different dimensions, and 10-minute treatment time versus the predicate's 10–15 minutes.

Biocompatibility testing per ISO 10993-5, 10993-10, and 10993-23; electrical safety and EMC per IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-83, and IEC 62133-2; eye safety per IEC 62471; and software validation per FDA's Human Factors guidance (February 2016).

The device is substantially equivalent because it uses the same fundamental technology (LED phototherapy), targets identical indications (wrinkles, acne, heating), is classified identically (Class II), and meets the same regulatory standards as the predicate device. Although there are minor differences in wavelength precision, intensity levels, and treatment duration, these variations fall within acceptable ranges observed across reference devices and do not raise new safety or effectiveness concerns. The device passed all biocompatibility, electrical safety, and software validation testing, demonstrating it performs comparably to the predicate.